PHASE I TRIAL OF AdRSV/& VIRUS WITH GANCICLOVIR IN 
PATIENTS WITH UNRESECTABLE MALIGNANT 
MESOTHELIOMA 
UPCC 2594 
c. Headache, confusion, alterations in consciousness: 5 to 17% of patients will have 
headache. Confusion occurs in 1 to 3% of patients. About 1 % of patients will have 
decreased consciousness, even coma. Seizures occur in 1% of patients. 
d . Liver blood test abnormalities: Some of the blood test which measure liver function 
can be abnormal in around 2% of patients. 
e. Nausea/vomiting: occurs in 2% of patients. 
f. Kidney function: Decreased in function in 18% of patients although these patients were 
on other drugs which could alter kidney function. 
g . Can cause irritation to veins (phlebitis) 
MEASURES TO BE TAKEN TO MINIMIZE RISKS. DISCOMFORTS AND 
INCONVENIENCES 
Blood tests : 
Pressure will be held at the sites of blood drawing to limit bruising. If I become light headed, I will be 
helped to a lying position to prevent fainting. 
Videothoroscopies and chest tube 
Several types of risks and discomforts can occur 
a) Cough. Medicine will be given to help reduce the coughing 
b) Bleeding. Blood tests will be done before the procedure to be sure that your blood clots normally. 
c) Pneumonia. Early antibiotic treatment will be given at the first sign of pneumonia. 
e) Allergic reactions to medications. I will be asked if I am allergic to any of the medications 
before they are given. 
0 Pain: Appropriate pain medications will be used. 
Complications caused by the virus 
a) Multiplication of the virus. An altered virus is being used that cannot multiply by itself. I will be 
monitored for any evidence that the virus is multiplying. 
Complications caused by the Ganciclovir 
a) Decreased white blood count. The drug will be discontinued if the white count falls significantly, 
therefore placing me at risk of infection. Additionally, antibiotics and medicine to increase the white 
blood cell count can be used. 
b) Headaches, confusion, unconsciousness. Headaches will be treated with pain medicine. If the more 
severe problems of confusion or alteration in level of consciousness occurs, the drug will be 
stopped 
c) Nausea/vomiting: Appropriate anti-nausea medicine will be used. 
d) Complication to eyes: in different patient settings (AIDS patients who receive ganciclovir for 
severe viral eye infection) a detached retina problem has been seen. Any problem concerning 
the eye/vision will be evaluated by an ophthalmologist. 
e) Decreased kidney function. The frequent blood monitoring will allow early discontinuation of the 
drug should this occur. 
EXPOSURE TO X-RAYS: 
The minimum number of x-rays will be used to obtain the safety information needed for the study. 
There are no side effects associated with these x-rays. 
[418] 
Recombinant DNA Research, Volume 20 
